Z-0474-2023Class II

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number...

Name: Z-0474-2023 Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number...
Creator: ConMed Corporation
Published: 2022-11-18
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2022-11-18 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187 on 2022-11-18. FDA classified it as Class II and gives the reason as "Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0474-2023
Classification: Class II
Status: Terminated
Initiated: 2022-11-18
Posted: 2022-12-09
Terminated: 2026-04-13
Recalling firm: ConMed Corporation
Product: Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 18, 2022, the firm notified affected customers through Urgent Medical Device Recall letters. Customers were instructed to review their inventory for any of the affected product and return affected product to the CONMED. Open or used devices should not be returned. If you have any questions or requests, please contact the Field Action Support Team at 1-800-448-6506 (8:00am to 7:00pm EST Monday through Friday) or email [email protected].
Quantity in commerce: 23,700 US; 5,225 OUS
Distribution: Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Product codes and lots: UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0474-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0474-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-21	2022-12-09

Product code GEI

K033003Class IISuction CoagulatorModern Medical Equipment Mfg., Ltd. / cleared 2004-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)